Quality and Quantity

Sometimes in turning over a new calendar year, we don’t take the time to appreciate all that has happened to get us where we are today. We’re more than half way through January and already the highlights of 2011 seem like a distant memory. In catching up with the events of 2011, in some respects, its been a great year for the oncology industry.

There were several “firsts” in 2011, but perhaps what is inspiring from 2011 is the quality of firsts in the approvals of new cancer treatments. With the U.S. Food and Drug Administration’s approval of the immunotherapy, Yervoy, in March, BMS holds the distinction of developing the first FDA-approved drug shown to prolong the lives of people with melanoma. A few months after the approval of Yervoy, Roche announced the approval of Zelboraf (vemurafenib; Genentech)—the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma—and touted with it, a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test—a companion diagnostic that will help determine if a patient’s melanoma cells have the mutation.

In a NSCLC first, Xalkori (crizotinib; Pfizer) was approved in August 2011 for a subset of late-stage NSCLC patients who express the abnormal anaplastic lymphoma kinase (ALK) gene. It, too, comes with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene. It is estimated that 4%-7% of NSCLC patients have the mutation, and the genetic test—Vysis ALK Break Apart FISH Probe Kit—is another first-of-a-kind to help make the determination.

Since diagnostic tests help to identify which patients are most likely to benefit from a treatment, while sparing others from unnecessary side effects and cost, pressure is mounting for companies to develop diagnostic tests along with new drug approvals, thereby accelerating the promise of personalized medicines in oncology.

In 2011, we also saw some firsts where there hadn’t been any before. For instance, the first and only treatment indicated for patients with myelofibrosis – Jakafi (ruxolitinib; Incyte) was approved. And, we also saw the first new drug in more than 30 years to be approved for treatment of relapsed or refractory Hodgkin’s lymphoma, as well as analplastic large cell lymphoma (Adcetris; Seattle Genetics, Inc). It is also well worth mentioning that a kinase inhibitor, vandetanib (Caprelsa; AstraZeneca), was approved and launched without waiting for trade name approval since there were no other FDA-approved medicines available for this type of rare medullary thyroid cancer.

It may not fit nicely into a first category, but Zytiga (abiraterone; Johnson & Johnson) was approved in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer in men who have received prior docetaxel chemotherapy, and helped personalized medicine in oncology gain momentum. Perhaps we can call it the first new drug to challenge Provenge and Taxotere in prostate cancer.

But At What Price?

But as we move into this new technological age, these personalized advancements come with a high price. Perhaps the most shocking is the $120,000 BMS is charging for a complete course of Yervoy treatment—four infusions over a three-month period. But, regarding price, there’s also positive news. The cost for patients receiving Roche’s Zelboraf is less than half of Yervoy (depending on the course of treatment) with a monthly price tag of roughly $9,400, making a 6-month course of treatment $56,400.

Similar to the Zelboraf price is Xalkori which stays under the $10,000 a month range with a cost of $9,600, while Jakafi is expected to cost $7,000 per month, or $84,000 for a year’s supply. Seattle Genetics announced that the price of its drug, Adcetris, would be $13,500 per dose. Analysts have estimated a course of treatment with the drug to range from $94,000 to $121,500. Maybe this is the first year we’ve seen a product come out with a price tag that is half the cost of its competitor (Zelboraf vs Yervoy)—thank you companion diagnostics, subsets of patients, and responsible companies.

Comparing 2011 to 2010, there were several more label expansions in 2010 than there were in 2011, but no matter how you cut it, we saw maturation of the personalized oncology pipeline and great clinical progress in 2011. I’m looking forward to the continued advancements in personalized medicines in 2012.

The Cancer Center Business Summit (http://www.CancerBusinessSummit.com) is a nationally recognized educational resource which deals with oncology/cancer care delivery, oncologist-hospital alignment and integration, and the business, legal, and financial models associated with such initiatives.

Each year, in conjunction with its annual conference, the Summit conducts a research survey of current trends affecting the oncology/cancer care sector. In keeping with this year’s theme, Achieving Accountable Cancer Care, the 2011 survey explored the positioning and payment re-design for oncology services within accountable care initiatives, whether such initiatives are in direct response to federal health reform (accountable care organizations – ACOs) or otherwise.

Phone interviews were conducted with 36 pre-qualified healthcare organizations to identify:
• The structuring/positioning of oncology services within integrated and ACO-like organizations and
• Payment/reimbursement re-design methodologies being undertaken in oncology

Key Findings from the Survey

1. In the context of ACO planning, oncology/cancer services are not considered an organizational priority for achieving cost savings compared to other chronic health conditions, for example, diabetes, chronic obstructive pulmonary disease (COPD) or heart disease.

Reasons cited were:
• Oncology too complex with a wide range of cost variability and unpredictability
• No clear definition of what constitutes cancer care
• Difficulty in segregating cancer-related costs from other costs for cancer patients with co-morbidities
• ACO principles are derived from primary care experience resulting in familiarity and predictability in non-cancer diseases

2. Despite low priority attention in the context of ACO planning, commercial payers are actively pursuing non-traditional and innovative methodologies for payment re-design for oncology services, typically at the community oncology level.

Much of this interest in bending the cost curve has surfaced within the last 6 months. Local and regional initiatives in oncology payment re-design are underway with United Healthcare (5 demonstration sites nationally), Aetna and a variety of Blue Cross plans, including oncology-specific payment re-design projects identified in Maryland, New Jersey, Tennessee, Michigan, Indiana, South Carolina and Southern California.

3. Re-design methodologies are focusing on drug cost reduction achieved through clinical pathways compliance. The predominant model has been to compensate oncologists at a premium for compliance with agreed upon clinical pathways. Typically, 80% compliance results in enhanced reimbursement and non-compliance results in penalties.

4. Trends are emerging to incorporate programs that result in reduced treatment-related emergency room visits and hospitalizations, and in rationalized end-of-life planning—all features of the so-called “oncology medical home” model.

A new sub-industry has surfaced to serve as middlemen in matching health plans with oncologists in transforming to the new oncology accountable care processes. Current front runners in this “match making” business include Aetna (through its acquisition of Medicity), Cardinal P4 and Proventys (through its affiliation with NCCN).

5. Despite the initial lack of interest in oncology as foundational to an ACO, community oncologists should not be discouraged. A viable strategy is “watchful waiting,” that is remain attuned but uncommitted to any ACO dynamics taking place in the local market.

In the interim, take the initiative with other like-minded oncologists to organize to scale as a specialist “neighbor” to someone else’s ACO. One example of organizing to scale is for oncology practices to develop regional, clinically-integrated oncology networks based on the care process transformation and payment re-design principles of the oncology medical home model.

Trends to Watch for Moving Forward into 2012

1. Expect to see an acceleration in health plan experimentation beyond pathways with programs that incorporate care processes to manage ER utilization, hospitalization and advance care planning—the features of the oncology medical home model.

2. Expect to see increased interest in oncology practices organizing to serve as specialist “neighbors” of primary care medical homes—the building block of ACOs.

3. Expect to see renewed interest in compatible oncology practices organizing to scale as clinically integrated oncology networks with common treatment pathways and third party health information exchanges (HIE) bringing data connectivity and advanced informatics and reporting capabilities to such networks.

4. Watch for oncology “bundled pricing” as the next oncologist-hospital alignment frontier. The recently announced CMI “Healthcare Innovation Challenge” may be a potential foot-in-the-door with Medicare in this regard.

By:
Ronald Barkley, MS, JD is President of Cancer Center Business Development Group and Co-Founder and Co-Chair of the Cancer Center Business Summit. Mr. Barkley can be reached at 603.472.2285 or rbarkley@ccbdgroup.com.

This blog is a companion piece to an article recently published in our November issue of OBR green titled “Consolidations Come with Concerns as NCI Cooperative Groups Restructure.” Enjoy the blog and then dig a little deeper by reading the OBR green article here.

Prior to the recent consolidations, 10 Cooperative Groups had been sharing that allotment ($150M from the NCI). With roughly 100 phase 3 trials with 20,000 patients and 200 phase 2 trials with 4,000 patients, that works out to only $500K per trial. These Groups are instrumental in establishing standards of cancer patient care and methods for clinical research. Each year they produce over 200 peer-reviewed publications. So, how do the Cooperative Groups accomplish so much with so little?

One answer is that the overall Cooperative Group funding is actually around $360M. Thus, the NCI budget of roughly $150M is less than half of the overall funding. Notably, one-third of the overall funding comes from institutional cost sharing ($88M) and pro bono investigator time ($28M), according to a September 2010 analysis by Judith A. Hautala, PhD, of the Science and Technology Policy Institute (STPI).

Additionally, a quarter of annual cash expenditures come from non-NCI sources, in the form of industry support at $41M (11% of overall Cooperative Group funding), philanthropic support at $6M (1.5%), and other support from sources such as parent institutions and state funds at $9M (2.5%).

The STPI analysis found that the fixed cost to establish and operate a Cooperative Group trial was $1.5M. Infrastructure costs make up 50%-60% of the budget of most of the Groups, with budgets for infrastructure ranging from $15 to $30M. The largest portion of infrastructure costs is statistics and data management (30%-40%), followed by core services (14%-30%). Each phase 3 or phase 2 patient accrual has infrastructure costs of about $3K.

Note that infrastructure costs also include scientific leadership, and the cost of the time commitments of those involved are largely met through $27.5M in pro bono time. This time is either donated by investigators or covered by their home institutions.

Besides infrastructure, patient accrual is the other large piece of Cooperative Group budgets. The estimated real cost of patient accrual is $6K per patient, according to the STPI analysis. While the NCI reimbursement rate has increased from $2K to $5K for phase 2 trials, most phase 3 trials reimburse $2K per patient, though additional funding is available for some complex phase 3 trials. These reimbursement rates do not pay the real cost of patient accrual.

Patients enroll in Cooperative Group trials at cancer centers, academic medical centers, and community oncology practices. Accrual costs are reimbursed at these sites through institutional NIH U10 awards ($5M), Group U10 sub-awards ($12M), per case reimbursements ($52M), and community clinical oncology program accrual reimbursements ($19M). After accounting for these funding mechanisms, over 60% of accrual costs are met through institutional cost sharing ($88M).

Together, pro bono time and institutional cost sharing cover $118M in costs. Consequently, volunteer buy-in is a key component of the success of the Cooperative Groups. Investigator and institutional support account for much of the strength of the Groups. Now the Groups are merging, and concerns have arisen about how this altruistic structure will be affected by these mergers. Meanwhile, their budget from NCI has remained flat.

by Kathy Boltz, PhD

To further explore the challenges of sustaining the Groups as they merge and evolve, please go to the November issue of OBR green.

November marks Pancreatic Cancer Awareness Month.  According to the American Cancer Society, more than 44,000 new cases of pancreatic cancer will be diagnosed in the U.S. and over 37,000 deaths are expected from the disease in 2011.  It has the highest mortality rate of all major cancers; 74% of patients die within the first year of diagnosis and 94% of patients die within five years[i].  Out of the top 15 cancer sites, pancreatic cancer is the only one with a five-year relative survival rate in the single digits [6%][ii].

Visibility for the disease is on the rise following the recent deaths of Apple, Inc. (AAPL) co-founder Steve Jobs and Ralph Steinman, a cell biologist who died several days before being named one of three winners for the 2011 Nobel Prize in Medicine.  While awareness is increasing, there is an urgent need for more effective treatments and diagnostics to detect the disease earlier due to the fact that the number of new pancreatic cancer cases is projected to increase by 55% from 2010 to 2030[iii].

Difficult Disease

The disease remains one of the most difficult to treat due to its extreme resistance to treatment and few early symptoms.  At the time of initial diagnosis, 50% of patients have distant metastases to the liver or peritoneal surface, and more than 80% of the remaining patients have locally advanced tumors [confined to the pancreas but unresectable][iv]. The majority of pancreatic tumors [95%] are adenocarcinomas that mainly develop from exocrine cells in the tissues of the pancreas[v]. The tumors are characterized by an aggressive behavior with a fast progression rate that makes them highly metastatic. In contrast, neuroendocrine tumors of pancreatic origin [pancreatic NET, also known as islet cell tumors] are not as common [<2%] and are considered less deadly[vi].

Illustrating the difference between the two, Hollywood actor Patrick Swayze was diagnosed with stage IV pancreatic exocrine cancer that had already spread to the liver in March 2008 and lost his battle with the disease in September 2009 at the age of 57.  Apple’s Steve Jobs underwent surgery for pancreatic NET in 2004 and didn’t succumb to the disease until October 2011 at the age of 56.

Treatment for Organ Confined Disease

In terms of treatment, surgical removal of the tumor represents the best option for pancreatic cancer patients without invasion into surrounding organs or distant metastasis.  Unfortunately, only 15–20% of all patients are candidates for potentially curative surgery[vii].  Depending on the tumor localization, pancreaticoduodenectomy [Whipple procedure], distal, or total pancreatectomy can be performed.  However, even with an optimal curative surgery, metastases often occur.  Median survival time without evidence of recurrent disease is 21.2 months after surgical resection[viii].

Treatment for Locally Advanced/Metastatic Disease

For locally advanced or metastatic disease, an effective single agent for pancreatic cancer remains elusive and treatment is still palliative rather than curative.  Since its approval in 1997, Eli Lilly’s (LLY) Gemzar® [gemcitabine] is the only single agent that improves symptoms and overall survival [OS] in patients with locally advanced or metastatic pancreatic exocrine cancer.  However, gemcitabine is associated with a modest median OS of 5.7 months and one-year probability of survival rate of 18%[ix]. No confirmed objective tumor responses were observed in the pivotal study.

Beyond Single Agent Gemcitabine

At least 35 Phase II trials of gemcitabine-containing regimens and 11 randomized Phase III trials have been performed to improve the efficacy of gemcitabine alone, but the progress to date has been incremental at best[x].  In these 46 trials, overall response rates ranged from 5% to 58% in the Phase II studies and 4.4% to 38.5% in the Phase III studies.  Median OS ranged from 4 months to 13.1 months in the Phase II studies and 5.4 months to 9 months in the Phase III studies.  Inclusion of heterogeneous patient populations in many of these studies may have confounded the results, as the median survival time for patients with metastatic disease and locally advanced disease is 3–6 and 9-13 months, respectively[xi].  The only successful combination approved by the FDA in 2005 is gemcitabine plus Roche/Astellas Pharma’s Tarceva® [erlotinib], which modestly increased the median OS to 6.4 months and one-year survival to 23%.

Hope on the Horizon

Despite the long list of past failures, drug developers continue to explore new options for treating pancreatic cancer and more than a dozen new treatments are currently being evaluated in clinical trials [see Table 1].  One product was recently approved and several programs have demonstrated encouraging results with data from pivotal trials due in the next 6-12 months.  While a comprehensive review of investigational pancreatic cancer therapies is beyond the scope of this article, we briefly highlight some of the more high profile pancreatic treatments below:

Amgen, Inc. (AMGN)

Amgen is developing AMG 479, an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor [IGF-1R], which plays an important role in the regulation of cell growth and survival.  At the 2010 American Society of Clinical Oncology [ASCO] Annual Meeting, Amgen announced results from a Phase 2 study demonstrating that the addition of AMG 479 to gemcitabine resulted in an OS rate at six months of 56.6% versus 50.1% with gemcitabine alone[xii]. Median OS was 7.3 months versus 6.2 months in the gemcitabine arm.  Amgen initiated a Phase III trial with AMG 479 for metastatic pancreatic cancer in the second quarter of 2011 with data expected in late 2013 or 2014 [ClinicalTrials.gov identifier NCT01231347].  This trial focuses on metastatic disease and therefore should represent a homogeneous patient population where the median OS is expected to be 3–6 months in the control arm.

Celgene Corporation (CELG)

Historically known more for its franchise in treating blood cancers, Celgene moved into the realm of solid tumors through its 2010 acquisition of Abraxis BioScience, Inc. for $2.9 billion.  As a result, Celgene is now developing Abraxane® [paclitaxel protein-bound particles for injectable suspension] for the treatment of metastatic pancreatic cancer.  Abraxane is currently approved for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy[xiii].

In October 2011, positive Phase I/II study results with Abraxane in combination with gemcitabine in 67 patients with advanced pancreatic cancer were published in the Journal of Clinical Oncology[xiv].  In the Phase II component of the study, the overall response rate was 48% [21/44 patients], median OS was 12.2 months, and the one-year survival rate for patients was 48%.  This compares favorably with the median OS of 5.7 months and one-year probability of survival rate of 18% with single-agent gemcitabine.

The combination of Abraxane and gemcitabine is now the treatment arm of an ongoing, international, randomized Phase III clinical trial for patients with metastatic pancreatic cancer [ClinicalTrials.gov identifier NCT00844649].  Importantly, this study specifically excludes patients with only locally advanced disease and therefore represents a homogeneous patient population where the median OS is expected to be 3–6 months in the control arm.

Clovis Oncology, Inc. (private)

In November 2009, Clovis licensed rights from Clavis Pharma for CO-101 in the U.S., E.U., and select other countries.  CO-101 is an investigational, lipid-conjugated derivative of gemcitabine, currently in a pivotal Phase II randomized, open-label, multicenter study comparing CO-101 with gemcitabine as first-line therapy in patients with metastatic pancreatic adenocarcinoma [ClinicalTrials.gov identifier NCT01124786].  CO-101 is designed to improve upon the efficacy of gemcitabine by enabling the drug to enter cancer cells without requiring membrane expression of transporter proteins.  As a hydrophilic molecule, the entry of gemcitabine into tumor cells is dependent upon the expression of specific membrane transporter proteins, particularly human equilibrative nucleoside transporter 1 [hENT1].  Data from the pivotal Phase II trial are expected in the first half of 2012 and the inclusion criteria for only Stage IV patients [metastatic] represents a homogeneous population to study in this trial.

In April 2010, Clovis Oncology, Inc. and Ventana Medical Systems, Inc. entered into a collaboration for the development of a hENT1 immunohistochemistry [IHC] assay, which will be used in Clovis’ CO-101 clinical trials to identify patients with low level tumor expression of hENT1 protein.  Approximately 50% of pancreatic cancer patients have been shown to have low tumor expression of hENT1 and low levels of tumor hENT1 expression have been shown to correlate with poor survival outcomes after gemcitabine therapy[xv].  These observations support the hypothesis that limited tumor uptake of gemcitabine in hENT1-low patients is responsible for a poor treatment effect in many patients and is an excellent example of a biomarker-driven clinical strategy.

Novartis AG (NVS)

In May 2011, the FDA approved Afinitor® (everolimus) by Novartis AG (NVS) for the treatment of progressive pancreatic NET in patients with unresectable, locally advanced or metastatic disease. Afinitor is an allosteric inhibitor of mammalian target of rapamycin [mTOR], a serine-threonine kinase, downstream of the PI3K/AKT pathway that is dysregulated in several human cancers.  Approval of Afinitor represents the first new therapy for pancreatic NET in the US in nearly 30 years[xvi].  The approval was based on Phase III data from the RADIANT-3 [RAD001 In Advanced Neuroendocrine Tumors] trial, showing treatment with Afinitor plus best supportive care more than doubled median progression-free survival [PFS], or time without tumor growth, from 4.6 to 11.0 months and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET.

Threshold Pharmaceuticals, Inc. (THLD)

At the 2011 ASCO Gastro Intestinal Cancers Symposium, Threshold Pharmaceuticals presented results with its hypoxia-activated prodrug, TH-302, in combination with gemcitabine in 47 patients with previously untreated, locally advanced, unresectable or metastatic pancreatic adenocarcinoma[xvii].  Of the 43 evaluable patients, one patient [2%] demonstrated a complete response as measured by RECIST [Response Evaluation Criteria In Solid Tumors] and 8 patients [19%] had a partial response.  In the gemcitabine plus TH-302 treatment arms, median OS was 8.5 months.  While this compares favorably with the median OS of 5.7 months with single-agent gemcitabine, recall that in 35 Phase II trials of gemcitabine-containing regimens in heterogeneous patient populations the median OS ranged from 4 months to 13.1 months.

In June 2011, Threshold Pharmaceuticals completed enrollment of patients with first-line, locally advanced, unresectable or metastatic pancreatic adenocarcinoma.  The company expanded the study’s enrollment target from the original 165 patients to at least 200 patients.  As mentioned earlier, inclusion of a heterogeneous patient population may confound the study results [expected before the end of 2011], as the median OS for patients with metastatic disease and locally advanced disease is different.

Conclusion

As we approach Pancreatic Cancer Awareness Month, visibility for the disease is on the rise following recent high-profile deaths.  Despite numerous late-stage failures, more than a dozen products are currently in clinical trials with key data expected in the next 6-12 months.  Going forward, early detection using biomarkers, more effective treatments, and novel drug targets could provide new hope for the treatment of this deadly disease.

NOTE: For more information, please visit the Pancreatic Cancer Action Network [http://www.pancan.org], a national organization creating hope in a comprehensive way through research, patient support, community outreach and advocacy for a cure.

Table 1. Baker’s Dozen in Active Clinical Development for Pancreatic Cancer

Company	Product	Class	Stage
Aduro BioTech, Inc. (private)	Cancer Vaccines CRS-207 and GVAX Pancreas	Immunotherapy	Phase II
Amgen (AMGN)	AMG 479 (ganitumab)	Immunotherapy	Phase III
Celgene (CELG)	Abraxane	Chemotherapy	Phase III
Celgene (CELG) and GlobeImmune (private)	GI-4000	Immunotherapy	Phase II
Clovis Oncology	CO-101	Chemotherapy	Phase II
Immunomedics (IMMU)	90Y-hPAM4	Radiopharmaceutical	Phase Ib
Infinity Pharma (INFI)	IPI-926	Signal transduction inhibitor	Phase Ib/II
NewLink Genetics (private)	HyperAcute®-Pancreas (Algenpantucel-L)	Immunotherapy	Phase III
Novartis AG (NVS) and Bayer Schering Pharma AG (BAYRY.PK)	Vatalanib (PTK787/ZK-222584)	Kinase inhibitor	Phase I/II
Oncolytics Biotech (ONCY)	Reolysin®	Reovirus	Phase II
Pharmacyclics (PCYC)	PCI-27483	Signal transduction inhibitor	Phase II
Seattle Genetics (SGEN)/Astellas Pharma (ALPMY.PK)	ASG-5ME	Immunotherapy – drug conjugate	Phase I
Threshold Pharmaceuticals (THLD)	TH-302	Chemotherapy	Phase II

References

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[i] American Cancer Society. Cancer Facts & Figures 2011. Atlanta: American Cancer Society; 2011 at http://www.cancer.org/Research/CancerFactsFigures/CancerFactsFigures/ACSPC-029771

[ii] SEER Cancer Statistics Review, 1975-2007, National Cancer Institute. Bethesda, MD. Altekruse SF, Kosary CL, Krapcho M, et al (eds). http://seer.cancer.gov/csr/1975_2007/, based on November 2009 SEER data submission, posted to the SEER web site, 2010.

[iii] Future of cancer incidence in the United States: burdens upon an aging, changing nation. Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. J Clin Oncol. 2009 Jun 10;27(17):2758-65. Epub 2009 Apr 29.

[iv] Pancreatic adenocarcinoma. Howard TJ. Curr Probl Cancer. 1996 Sep-Oct;20(5):281-328.

[v] PET and PET-CT of malignant tumors of the exocrine pancreas [Article in German]. Reske SN. Radiologe. 2009 Feb;49(2):131-6.

[vi] Population-based study of islet cell carcinoma. Yao JC, Eisner MP, Leary C, Dagohoy C, Phan A, Rashid A, Hassan M, Evans DB. Ann Surg Oncol. 2007 Dec;14(12):3492-500. Epub 2007 Sep 26.

[vii] Pancreatic Cancer. U.S. News and World Report Health. http://health.usnews.com/health-conditions/cancer/pancreatic-cancer/treatment

[viii] Outcomes following resection of pancreatic adenocarcinoma: 20-year experience at a single institution. Helm JF, Centeno BA, Coppola D, Druta M, Park JY, Chen DT, Hodul PJ, Kvols LK, Yeatman TJ, Carey LC, Karl RC, Malafa MP. Cancer Control. 2008 Oct;15(4):288-94.

[ix] Gemcitabine prescribing information at http://pi.lilly.com/us/gemzar.pdf

[x] Cytotoxic chemotherapy for pancreatic cancer: Advances to date and future directions. Xiong HQ, Carr K, Abbruzzese JL. Drugs. 2006;66(8):1059-72. Review.

[xi] Efficacy and factors affecting outcome of gemcitabine concurrent chemoradiotherapy in patients with locally advanced pancreatic cancer.

Huang PI, Chao Y, Li CP, Lee RC, Chi KH, Shiau CY, Wang LW, Yen SH. Int J Radiat Oncol Biol Phys. 2009 Jan 1;73(1):159-65. Epub 2008 May 26.

[xii] A placebo-controlled, randomized phase II study of conatumumab (C) or AMG 479 (A) or placebo (P) plus gemcitabine (G) in patients (pts) with metastatic pancreatic cancer (mPC). H. L. Kindler, D. A. Richards, J. Stephenson, L. E. Garbo, C. S. Rocha Lima, H. Safran, J. S. Wiezorek, E. G. Feigal, S. Bray, C. Fuchs. J Clin Oncol 28:15s, 2010 (suppl; abstr 4035).

[xiii] Abraxane prescribing information at http://www.abraxane.com/docs/Abraxane_PrescribingInformation.pdf

[xiv] Gemcitabine Plus nab-Paclitaxel Is an Active Regimen in Patients With Advanced Pancreatic Cancer: A Phase I/II Trial. Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. J Clin Oncol. 2011 Oct 3. [Epub ahead of print]

[xv] Human equilibrative nucleoside transporter 1 levels predict response to gemcitabine in patients with pancreatic cancer. Farrell JJ, Elsaleh H, Garcia M, Lai R, Ammar A, Regine WF, Abrams R, Benson AB, Macdonald J, Cass CE, Dicker AP, Mackey JR. Gastroenterology. 2009 Jan;136(1):187-95. Epub 2008 Oct 7.

[xvi] Company press release May 6, 2011 – Novartis gains FDA approval for Afinitor® as first new treatment in nearly three decades for patients with advanced pancreatic NET

[xvii] Clinical benefits TH-302, a tumor-selective, hypoxia-activated prodrug, and gemcitabine in first-line pancreatic cancer (PanC). M. J. Borad, E. G. Chiorean, J. R. Molina, A. C. Mita, J. R. Infante, W. R. Schelman, A. M. Traynor, G. Vlahovic, D. S. Mendelson, S. G. Reddy. J Clin Oncol 29: 2011 (suppl 4; abstr 265).

by Michael D. Becker and Janet L. Dally

Senior Partners

MD Becker Partners, LLC

Though oncologists are well aware of molecular-level testing, the concept may be new for patients. When clinicians discuss treatment plans, patients often focus on little beyond the word “cancer” because their attention is focused on their fear, anxiety, and uncertainty. After diagnosis, patients often call their clinician’s office to rehash the conversation because they don’t remember what was said. Also, few patients clearly understand the technologies and how they can lead to personalized treatments. A new website, www.IsMyCancerDifferent.com, helps in patient understanding by providing expert information on molecular-level testing in a consumer-friendly, patient-driven format.

We discussed this new website with Dr. April Latrice Speed, a breast specialist at Dekalb Medical Hillandale in Lithonia, GA. She explained that the site empowers patients to drive the conversation about their individualized cancer treatment plan. For oncologists, this website helps to communicate to patients the concepts of molecular-level testing and how this testing can provide crucial information to guide diagnosis, prognosis, and treatment planning.

“The website helps to reinforce the office discussion in the comfort of your own home. You don’t plan for cancer. You can’t process and wrap your head around it. It allows you to have a friend at your house and basically rehash what your clinician just told you. It’s a format that is compassionate, comprehensive, and not intimidating,” said Dr. Speed.

The advice on www.IsMyCancerDifferent.com is delivered from the patient’s perspective, while providing interface with experts. It is patient-friendly and has consumer-driven content. The majority of other websites have a format that is driven by clinicians or else they are strictly consumer driven without expert interface.

This website “puts the power in patient’s hands. It’s a game changer,” stated Dr. Speed. Patients can access information at low impact to their wallet since no travel or time off of work is needed. The information equalizes the potential for patients to get good treatment, even when they do not live in an area with top-notch facilities nearby.

“The website puts the patient behind the wheel,” said Dr. Speed.

The website is sponsored by Clarient, which is a GE Healthcare Company, and by N-of-One. The content is reviewed for accuracy by the president of N-of-One, Jennifer Levin Carter, MD, MPH, and is also reviewed by the legal and regulatory team from Clarient/GE Healthcare.

Clarient provides comprehensive, cancer-diagnostic laboratory services, and is developing proprietary companion diagnostic tests for therapeutics in breast, prostate, lung, and colon cancer, along with leukemia/lymphoma. N-of-One provides access to cutting-edge technologies for cancer patients and their physicians.

by Kathy Bolz, PhD